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KMID : 1142220160110020201
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Regulatory Research on Food, Drug & Cosmetic
2016 Volume.11 No. 2 p.201 ~ p.209
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Recent Trend of International Guidelines for Genotoxicity Testing
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Kim Joo-Hwan
Ahn Il-Young
Noh Jong-Yoon
Park So-Eun
Yi Jung-Sun
Koh Kyoung-Yuk
Shon Soo-Jung
Lee Jong-Kwon
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Abstract
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Genotoxicity tests are defined as tests designed to evaluate the adverse effects of test substances on genes or chromosomes. These tests are required for selecting candidate substances in the process of developing new pharmaceuticals and for detecting potential carcinogens or mutagens. Genotoxicity tests for pharmaceuticals are generally conducted following International Conference on Harmonization of Technical Requirements for Registration of Pharmaceutical for Human Use (ICH) or Orgnisation for Economic Cooperation and Development (OECD) guidelines. At the same time, new test methods are being developed as science and technology have advanced and a number of chemicals were found to be false-positive in existing in vitro genotoxicity tests. Taking that into account, ICH and the OECD have established new guidelines for genotoxicity testing or revised existing ones. ICH combined two of its guidelines into the Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use (S2(R1)). S2(R1) includes two options for the standard battery, criteria for determining the highest dose in in vitro tests, integration of repeated dose testing with in vivo genotoxicity testing, application of new genotoxicity tests, evaluation of test results and strategies for follow-up testing. OECD guidelines for genotoxicity testing, meanwhile, state specific test methods that are not addressed in ICH guidelines. The OECD has recently abolished its 6 Test Guidelines, which have been less frequently used, and developed new ones. In addition, it has modified the criteria for test result evaluation, historical data management and laboratory proficiency assessment in its existing Test Guidelines. Changes were also made to the criteria for determining the highest dose in in vitro tests. In step with this global trend, it would be necessary to revise relevant domestic regulations for developing pharmaceuticals in accordance with internationally agreed standards, thus further strengthening the Korean pharmaceutical industry's global competitiveness.
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KEYWORD
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Genotoxicity Test, ICH, OECD, Guideline
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Listed journal information
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